MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-13 for TECNIS SYMFONY ZXR00 ZXR00U0225 manufactured by Johnson & Johnson Surgical Vision, Inc..
[183371648]
Date of event: exact date not provided, best estimate is between (b)(6) 2019 - (b)(6) 2020. (b)(4). Device evaluation: product testing could not be performed because the product was not returned. The complaint cannot be confirmed. Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications. A search revealed that no similar complaints were received from this production order. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[183371649]
It was reported that a zxr00 intraocular lens (iol) was explanted from the patient? S right eye due to the patient experiencing glare, unable to drive at night, and blurry distance vision. Doctor mentioned that the patient had an intolerance to the diffractive lens which was exacerbated by vitreous opacities. It was also stated that vitrectomy was performed and the replacement lens is a model za9003 22. 0 diopter iol. Patient outcome is reported as patient is happy with vision and glare has resolved. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00122 |
| MDR Report Key | 9827912 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | VAN SWIETENLAAN 5 |
| Manufacturer City | GRONINGEN 9728NX |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9728 NX |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECNIS SYMFONY |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | POE |
| Date Received | 2020-03-13 |
| Model Number | ZXR00 |
| Catalog Number | ZXR00U0225 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-03-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |